| CTRI Number |
CTRI/2023/06/054024 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
14/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
THERAPEUTIC BOTULINUM TOXIN INJECTION IN MASSETER MUSCLE FOR DEEP BITE CORRECTION. |
|
Scientific Title of Study
|
EFFECT OF INTRAMUSCULAR ADMINISTRATION OF BOTULINUM TOXIN ON TEMPORALIS AND MASSETER DURING TREATMENT IN SKELETAL DEEP BITE PATIENTS - A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rama Raji Sankaranarayanan |
| Designation |
Post graduate student |
| Affiliation |
Saveetha Institute of medical and technical sciences |
| Address |
Clinic No.27, 5th floor,
Department of orthodontics and dentofacial orthopedics,
162, Saveetha Dental College, Velapanchavadi, Poonamalle high road
Clinic No.27, 5th floor,
Department of orthodontics and dentofacial orthopedics,
162, Saveetha Dental College, Velapanchavadi, Poonamalle high road
Chennai
TAMIL NADU
600077
India |
| Phone |
7338883454 |
| Fax |
|
| Email |
ramaraji.iyer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harish Babu |
| Designation |
Professor |
| Affiliation |
Saveetha Institute of medical and technical sciences |
| Address |
Clinic No.27, 5th floor,
Department of orthodontics and dentofacial orthopedics,
162, Saveetha Dental College, Velapanchavadi, Poonamalle high road
Clinic No.27, 5th floor,
Department of orthodontics and dentofacial orthopedics,
162, Saveetha Dental College, Velapanchavadi, Poonamalle high road
Chennai
TAMIL NADU
600077
India |
| Phone |
9360575950 |
| Fax |
|
| Email |
harishortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rama Raji Sankaranarayanan |
| Designation |
Post graduate student |
| Affiliation |
Saveetha Institute of medical and technical sciences |
| Address |
Clinic No.27, 5th floor,
Department of orthodontics and dentofacial orthopedics,
162, Saveetha Dental College, Velapanchavadi, Poonamalle high road
Clinic No.27, 5th floor,
Department of orthodontics and dentofacial orthopedics,
162, Saveetha Dental College, Velapanchavadi, Poonamalle high road
Chennai
TAMIL NADU
600077
India |
| Phone |
7338883454 |
| Fax |
|
| Email |
ramaraji.iyer@gmail.com |
|
|
Source of Monetary or Material Support
|
| Royal biotech
Near, Office No. A-309, Sobo Center, Sardar Patel Ring Rd, South Bopal, Ahmedabad, Gujarat 380058 |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and hospitals |
| Address |
162, Saveetha Dental College, Velapanchavadi, Poonamalle high road |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sankaranarayanan |
37, Krishnamachari Nagar 1st street alapakkam, chennai -116 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rama Raji S |
Saveetha Dental College and hospitals |
Department of orthodontics and dentofacial orthopedics, Room no.27, 5th floor, Dental hospital block, 162, saveetha dental college, velapanchavadi, poonamalle high road
Kancheepuram
TAMIL NADU |
7338883454
ramaraji.iyer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Botulinum toxin i.m. |
Intramuscular administration of botulinum toxin in the masseter 25 units for 1 cycle in each masseter at 3 month interval. |
| Comparator Agent |
Saline i.m. |
Intramuscular administration of saline 25 units for 1 cycle at 3-month intervals in each masseter. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Skeletal deep bite
Reduced posterior and anterior facial height
|
|
| ExclusionCriteria |
| Details |
Poor periodontal status
Blood dyscariasis
Retreatment orthodontic patients
Missing posterior teeth
Hypersensitivity to botulinum toxin |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
LAFH
Posterior Dental height
Mandibular Plane angle
Muscle activity by EMG
Muscle thickness using ultrasound
Clinical overbite
|
T0- before administration of botulinum toxin masseter
T1- immediately after administration of botulinum toxin in the masseter
T2- 3 months after administration of botulinum toxin in the masseter |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
masseter muscle activity via EMG
masseter muscle thickness using ultrasound |
T0- before administration of botulinum toxin
T1 - immediately after |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Botulinum toxin is a Aim: To study the effects of intramuscular administration of botulinum toxin on the acceleration of posterior extrusion in skeletal deep bite correction in adults.
P= Adult skeletal deep bite patients treated orthodontically. I= Intramuscular masseter administration of Botox for orthodontic deep bite correction C= Orthodontic deep bite correction with extrusion mechanics. O= Acceleration of extrusion in orthodontic deep bite correction
Rationale : Botulinum toxin is a known neurotoxin. Low dose administration of Botox can reduce muscle activity. These neuromuscular changes produced by Botox can be used to prevent post treatment bite deepening in adults with deep bite.
Null hypothesis: Intramuscular administration of botulinum toxin deos not accelerate the deep bite correction in adults with skeletal deep bite. Alternate hypothesis: Intramuscular administration of botulinum toxin accelerates the deep bite correction in adults with skeletal deep bite.
Research question: Does intramuscular injection of botulinum toxin in masseter aid in acceleration of posterior extrusion in skeletal deep bite patients?
Variables: primary outcome: LAFH- COGS, Posterior dental heights, Mandibular plane angle, Clinical overbite and Secondary outcome : muscle activity and muscle thickness |